Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System
FDA premarket approval P130013/S025 · decided 2019-03-01
Approval details
- PMA number
- P130013
- Supplement
- S025
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System
- Generic name
- System, appendage closure, left atrial
- Applicant
- Boston Scientific Corp
- Date received
- 2018-12-07
- Decision date
- 2019-03-01
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- NGV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for approval for a manufacturing site, Synergy Health Ireland Ltd., (a STERIS Company), located at IDA Business and Technology Park, Srah, Tullamore, County Offaly, Ireland, as a new ethylene oxide (EO) sterilization site for the WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System.
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